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COVID-19: Moderna Asks FDA To Approve Vaccines For Those Ages 12 To 17

Moderna is asking for approval to use its vaccine on adolescents.
Moderna is asking for approval to use its vaccine on adolescents. Photo Credit: U.S. Air National Guard Senior Master Sgt. Andrew Moseley

Moderna has requested an emergency use authorization from the Food and Drug Administration (FDA) for its COVID-19 vaccine in adolescents between the ages of 12 and 17.

The company announced that clinical trials have shown that the vaccine has a 93 percent efficacy rate among adolescents, and has been proven to be safe.

If approved, it would be the second COVID-19 vaccine authorized for adolescents, joining the Pfizer-BioNTech vaccine, which was given the green light for use earlier this month.

In their study, Moderna found no cases of COVID-19 in participants who received two doses of the COVID-19 vaccine, while four were reported in the placebo group.

The study enrolled 3,732 participants ages 12 to less than 18 years in the US.

Side effects were largely mild or moderate, the company said, with the most common symptoms being arm pain and, after the second dose, headache, fatigue, muscle aches, or chills.

“We are pleased to announce that we have submitted for an emergency use authorization for our COVID-19 vaccine with the FDA for use in adolescents in the United States,” Moderna CEO Stéphane Bancel said. “We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents.

“We have already filed for authorization with Health Canada and the European Medicines Agency and we will file with regulatory agencies around the world for this important younger age population. We remain committed to helping to end the COVID-19 pandemic.”

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